The present invention is intended to disclose a novel method for the dosing of sterile vials which provides notable characteristics of novelty and inventive step.
The present invention relates to a method for the dosing of sterile vials which is applicable to medicinal products and is based on the principle disclosed in Patent Spanish 8902737 in the name of Probitas Pharma, S. A., for the preparation and dosing of sterile vials, in order to provide a guarantee of safety in the sterility of the dosing; in that patent, the vial is sterilized with the stopper and the cap fitted, the stopper having a special design so as to be fitted on the top of the vial without plugging it completely so that steam can enter during the sterilization cycle. Moreover, the assembly is protected by a protector which has a dual purpose since, on the one hand, it protects the interior of the vial against possible contamination and, on the other hand, it offers protection against possible accidental plugging of the vial during handling. This method represents a notable improvement in safety since the interior of the vial is exposed minimally to the environmental air and is only opened at the moment when the dosing is performed, the vial being re-plugged with the same stopper; this method also reduces the time of exposure with the vial open and, as a result, minimizes the potential danger of contamination.
The present invention considerably improves the correct sterile dosing of the vials by disclosing a method in which the following steps are performed in succession
a) assembling the stopper with the cap in a specific machine which has supply hoppers for the stoppers and caps that fit the assembly together automatically;
b) washing the vials in a specific machine for that task, in which the cleanliness of the vial is ensured;
c) fitting together the vial, stopper/cap, and protector in a device which is normally coupled to the output of the vial-washing machine and which cleans the interior of the stopper, fits the vial assembly together in the partial closure position, puts the protector in place, and then arranges the vials in trays for the loading of an autoclave;
d) a step of sterilization in the autoclave in which the vials arrive on trays disposed on tray-carrying trolleys, the sterilization being performed with pure steam with a vacuum cycle for complete sterilization of the assembly;
e) a vial-cooling step which is performed on the sterile side of the autoclave, minimizing the risk of air entering as the vial cools by reduction of the air density, this process taking place in a zone with maximum environment control and quality and a low laminar flow of filtered air (Class A);
f) loading the vials with their stoppers, caps, and protectors, into an accumulation turntable for intermediate collection purposes;
g) dosing and plugging in a zone of the dosing machine which is in Class A conditions and is subjected to a laminar flow that is normally horizontal; during this stage, the vial, from which the protector has previously been removed by a manipulator, is introduced with the stopper/cap assembly fitted in the partial closure position in a manner such that a manipulator removes the stopper/cap assembly and supports it whilst the dosing nozzle is positioned above the vial and doses the desired quantity of liquid of the sterile solution. The stopper/cap assembly is then replaced on the same vial, the said assembly being pressed as far as the total closure position, that is, leaving the vial hermetically sealed. During this stage, a video camera is provided and performs continuous recording related to the duration and time determined by the dosing machine.
In the filled state, there is no obstacle between the horizontal laminar flow and the mouth of the vial, which favours the protection of the sterile conditions of the vial;
h) a step of encapsulation under laminar flow with a machine which is connected to the dosing machine and performs the flanging of the cap in order to close it; this machine has, at its output, a system for marking the glass of the vial with laser beams; this identifies each vial and provides information on the time of dosing; together with the video recording, this enables the route followed and any dosing problems to be monitored;
i) discharging the vials into an output turntable of the machine which permits the collection and discharge thereof.